Depressive Disorder
Conditions
Keywords
rTMS, TMS, repetitive transcranial magnetic stimulation, major depressive disorder, major depression, MDD
Brief summary
This prospective, single-arm, open-label feasibility study will assess the safety, tolerability, and effectiveness of repetitive transcranial magnetic stimulation (rTMS) in patients with major depression (MDD) to test the hypothesis that remission rates can be increased by additional treatment sessions.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)
The treatment will be delivered by trained medical personnel.
Sponsors
Centre for Addiction and Mental Health
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
prospective, single-arm, open label feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* are outpatients * are voluntary and competent to consent to treatment * are between the ages of 18 and 85, inclusive * are able to adhere to the treatment schedule * pass the TMS safety-screening questionnaire * have had no change or initiation of any psychotropic medication in the 4 weeks prior to screening
Exclusion criteria
* previous rTMS treatment * have a history of substance dependence or abuse within the last 3 months * have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump * have active suicidal intent * have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD * have a diagnosis of any psychotic disorder * have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure confirmed diagnostically by neurological assessment (except those therapeutically induced by ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, dementia, stroke, neurologically confirmed diagnosis of traumatic brain injury, or multiple sclerosis. * if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study * clinically significant laboratory abnormality, in the opinion of the investigator * currently (or in the last 4 weeks) take more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy * non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview) * any significant cardiovascular or metabolic disorder or insult including, but not limited to: coronary artery disease, abnormal heart rhythms, heart failure, cardiac valve disease, congenital heart disease, cardiomyopathy, vascular disease, dyslipidemia, diabetes, or hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) (score 0-63, higher = more severe) | Baseline (week prior to treatment), on each treatment day, 1 week and 4 weeks post-treatment | Outcome measured by a change in depression score at baseline, before every treatment, and at 1 and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 12 or less is categorized as remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale 17-items (HDRS17) (score 0-52, higher = more severe) | Baseline (week prior to treatment) and after 1 week and 4 weeks post-treatment | Outcome measured by a change in depression score from baseline (week prior to treatment) to 1 week and 4 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A score of 7 or less is categorized as remission. |
Countries
Canada
Contacts
Primary ContactJonathan Downar, MD, PhD
Backup ContactEileen Lam
Outcome results
None listed